"Alerted.org

Job Description

The NPI Test Engineer is responsible for deploying new process changes to a variety of robotic production lines. A majority of the process changes will be software focused.

• Direct newly developed processes from concept to implementation in a live production environment:

o Create changes to documentation within Agile PLM to deploy new/altered test methods from the development team.

• Test Procedures/Datasheets, Equipment Qualifications, pFMEa, MVP.

o Coordinate execution of manufacturing protocols.

• TMV, IQ, Engineering Studies.

o Work with cross-functional engineering teams to finalize Engineering Change orders in Agile PLM.

• Software Quality, Operations Quality, R&D, Software Development.

• Develop and maintain scalable test methods that support multiple robotic production lines.

• Write, debug, and integrate Python scripts into a proprietary test framework in order to implement new test methods within the production environment.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• 2+ years of engineering experience, with experience implementing process changes to a commercial, regulated manufacturing environment.

• Strong understanding of hardware/software interaction.

• Familiarity with computerized test equipment and fixture design, ideally with some test procedure deployment background

• Strong communication skills, written and verbal. Ability to drive change with a variety of stakeholders. • Background in the medical device industry, with solid understanding of regulatory standards (e.g., MVP, PFMEAs, IQ protocols, FDA compliance).

• Gage R&R Analysis (Preferably with Minitab).

• 2+ years of hands-on Python scripting and test automation.

• Capital Equipment Manufacturing.

• Experience with robotic systems.

• Experience with GIT, Agile PLM, MES Camstar.